MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a right pulmonary vein isolation (rpvi) with the use of a thermocool® smart touch® sf bi-directional navigation catheter and a clot issue occurred.A steam pop occurred and the ablation stopped due to a temperature rise.The catheter was removed from the patient¿s body and a blood clot was found attached to it.The catheter was replaced and the procedure could be successfully completed without patient consequences.The physician commented that when he flushed the catheter before ablation, he felt that the irrigation did not come out firmly.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.The clot reported was assessed as a reportable mdr issue.The temperature issue was assessed as not a reportable mdr issue.If the temperature reading is high (higher than the user selected temperature cut-off); however, the system detects it and stopped the ablation, then the risk to the patient was remote.The irrigation issue was also assessed as not a reportable mdr issue.Intermittent or low irrigation was highly detectable by the physician.The most likely consequence was an intraprocedural delay the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

On 8/26/2020, the product investigation was completed.It was reported that a patient underwent a right pulmonary vein isolation (rpvi) with the use of a thermocool® smart touch® sf bi-directional navigation catheter and a clot issue occurred.A steam pop occurred and the ablation stopped due to a temperature rise.The catheter was removed from the patient¿s body and a blood clot was found attached to it.The catheter was replaced and the procedure could be successfully completed without patient consequences.Device evaluation details: the device was visually inspected and it was found in good conditions, no clot was found.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.Then, patency test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint regarding high temperature, inadequate irrigation were unable to duplicate during the product investigation.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10317038
• MDR Text Key: 200455207
• Report Number: 2029046-2020-00929
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30344081M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER